Kornimate/medical-research-clean huggingface dataset:
ar and er imaging in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: knowledge of breast cancer estrogen receptor (er) expression is of major importance in treatment-decision making. patients with er-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. whole-body tumor er-expression can be visualized by 18f-fluoroestradiol pet imaging (fes-pet). in addition to er, the androgen receptor (ar) is a potential new target in breast cancer. pet imaging with 18f-fluorodihydrotestosterone (18f-fdht) may allow visualization of tumor ar-expression. in the current study we will perform fes-pet and fdht-pet in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. molecular imaging of tumor ar- and er-expression may well be of value for future treatment decision-making.


Eligibility criteria:
inclusion criteria: 1. metastatic breast cancer, with at least one known metastasis outside of the liver 2. presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion) 3. postmenopausal status defined as one of the following: * age ≥60 years * previous bilateral oophorectomy * age \ 12 months in the absence of interfering hormonal therapies (such as lh-rh agonists and er-antagonists) * patients age \ 12 months and fsh \>24 u/l and lh \>14 u/l e. patient age \<60 years using lh-rh agonists should continue lh-rh-agonists until after the pet procedures 4. initially er-positive tumor histology. 5. ecog performance status 0-2. 6. signed written informed consent 7. able to comply with the protocol exclusion criteria: 1. use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study 2. life-expectancy ≤ 3 months
study of the effect of glutamine supplementation on chemotherapy induced toxicities in breast cancer patients

Conditions: Breast Cancer

Summary: glutamine, a non essential branched chain amino acid, is most important non toxic nitrogen carrier in body. it participates in variety of physiological functions. it is a major fuel source of enterocytes and is a substrate for gluconeogenesis in kidney, lymphocytes, and monocytes. it is also a nutrient in muscle protein metabolism in response to infection, inflammation and muscle trauma. the significance of glutamine to metabolic homeostasis becomes evident during periods of stress, when it becomes a conditionally essential amino acid. role of glutamine as protective agent in hepato-biliary dysfunction, in maintaining mucosal integrity of the gastrointestinal tract following its administration in patient with major bowel surgery as a supplement and part of tpn in critically ill patients and in patients of septicemia, is well established. however the role of glutamine supplementation in reducing or preventing chemotherapeutic agents induced toxicity in cancer patients is controversial.


Eligibility criteria:
inclusion criteria: * the patients \> 18 years of age * histologically or cytologically proven breast cancer * receiving cef chemotherapy cycles presently or in the past * the patients who will give informed consent to participate in the study * patients must have sufficient organ and marrow function * stage 1 neuropathy, subclinical neuropathy, surgery induced neuropathy exclusion criteria: * pregnancy * clinical/biochemical severe liver failure * clinical/biochemical severe renal dysfunction * refusal to participate in the study * patients who have received prior chemotherapy with paclitaxel. * patients who have neuropathy due to any known systemic or metabolic causes like diabetes, leprosy, nutritional deficiency induced (vit. b12) etc

Keywords: breast cancer chemotherapy epirubicin glutamine fec chemotherapy
feasibility of insomnia tracking and treatment in ibd

Conditions: Inflammatory Bowel Diseases; Insomnia

Summary: this study is a longitudinal clinical trial designed to characterize sleep patterns in individuals with inflammatory bowel disease (ibd) as well as to assess the feasibility of sleep intervention (cognitive behavioral therapy for insomnia (cbt-i)) in individuals with both insomnia and inflammatory bowel disease (ibd).


Eligibility criteria:
inclusion criteria (ibd participants): * documented ibd * mild to moderate crohn's disease or ulcerative colitis as measured by the physicians global assessment inclusion criteria (healthy participants) * no personal history of ibd * no personal history of irritable bowel syndrome (ibs) or celiac disease * no current gastrointestinal symptoms or concerns * no family history of ibd or celiac disease exclusion criteria (both ibd participants and healthy participants) * phq-9 depression score \> 15 * gad-7 anxiety score \> 15 * current alcohol or substance abuse * current narcotic use * unstable major psychiatric condition * current sleep apnea or restless leg syndrome * other problems that would interfere with study participation at investigator discretion

Keywords: cognitive behavioral therapy for insomnia (cbt-i) insomnia sleep crohn's disease ulcerative colitis
a long-term administration study of opc-41061 in patients with autosomal dominant polycystic kidney disease (adpkd) (2) [extension of study 156-05-002]

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: adpkd patients who were enrolled in study 156-05-002 will receive repeated oral administration of opc-41061 at doses of 15 mg twice daily (morning and evening). administration will be continued until the time of manufacturing and distribution approval of opc-41061 for adpkd in japan.


Eligibility criteria:
inclusion criteria: * patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002) * patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up. exclusion criteria: * patients with egfr of less than 15 ml/min/1.73 m2 * patients with any of the following complications: * uncontrolled hypertension * serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis) * patients with any of the following complications or history thereof: * clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity * inability to personally give consent due to a mental illness

Keywords: adpkd tolvaptan opc-41061
prognostic value of androgen receptor expression and mutations within oncogenes and tumor suppressor genes in patients treated for high risk prostate cancer with proton therapy (prx32)

Conditions: Prostate Cancer

Summary: retrospective review study for prognostic transcriptional output related to androgen receptor expression in patients treated for high risk prostate cancer with proton therapy


Eligibility criteria:
inclusion criteria: * adult patients (older than 18 years at time of treatment) with high risk prostate cancer who were treated with proton therapy at ufhpti/department of radiation oncology * patients treated between 6/10/2010 through 4/26/17 with at least 2 years follow up

Keywords: prostate cancer proton radiation
effect of consuming a combination of probiotic strains on postpartum depression

Conditions: Postpartum Depression

Summary: the objective of this trial is to evaluate the effect of consuming a combination of lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.

the mood disorders such as postpartum depression have a very high incidence. there is a relationship between a woman's microbiota and the risk of postpartum depression. the possibility of influencing the microbiota through probiotic treatments opens a door to the prevention and/or treatment of postpartum depression. therefore, the objective of this trial is to evaluate the effect of consuming a combination of lactobacillus during the pregnancy and lactation period on the incidence of postpartum depression.

Eligibility criteria:
inclusion criteria: * pregnant who is between 28-32 weeks of gestation. * normal development of pregnancy. * singleton pregnancy. * score ≥12 scale postpartum depression questionnaire edinburgh. * pregnant who has the firm intention of breastfeeding her child for at least the first month. * sign the informed consent. exclusion criteria: * have any breast pathology that makes it difficult or impossible to breastfeed. * consume other probiotic supplements during the study. * history of serious mental disorders other than affective disorders, whether or not currently under pharmacological treatment. * low expectation of adherence to the study protocol. * pharmacological treatment incompatible with the study. * non-compliance with the study protocol.

Keywords: probiotics depression postpartum
drug-eluting pta balloon dilatation catheter in the treatment of peripheral artery stenosis or occlusion

Conditions: Peripheral Arterial Disease; Iliac Artery Stenosis; Femoral Artery Stenosis; Popliteal Artery Stenosis; Iliac Artery Occlusion; Femoral Artery Occlusion; Popliteal Artery Occlusion

Summary: clinical study on safety and efficacy of zenflow™ drug-eluting pta balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion

the purpose of this study was to evaluate the safety and efficacy of zenflow™ drug-eluting pta balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional pta balloon dilatation catheter.

Eligibility criteria:
inclusion criteria: * aged from 18 to 85 years old, male or female * subject's target lesions were stenosis and/or occlusion * subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent exclusion criteria: * pregnant woman or who's pregnancy test is positive * lactation period woman or woman/man with fertility plan

Keywords: peripheral arterial disease drug-eluting pta balloon dilatation catheter late lumen loss（6 months）
the iscgm use and hypoglycemic episodes and fear of hypoglycemia in newly diagnosed type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of this trial is to investigate the impact of freestyle libre use compared to smbg on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes. this trial is conducted in university centers in poland (bialystok, krakow, poznan, zabrze).


Eligibility criteria:
inclusion criteria: * newly diagnosed type 1 diabetes (diagnosed based on the who criteria) no later than 6 months after the diagnosis. * insulin therapy: multiple daily injections, * in the investigator's opinion, the participant must be technically capable of using the freestyle libre system exclusion criteria: * current or past use of any continuous glucose monitoring system. * pump therapy. * known allergy to medical adhesives. * oral steroid therapy. * pregnancy or planning pregnancy within the study duration. * breast feeding. * dialysis treatment. * having a pacemaker. * unstable coronary heart disease. * cystic fibrosis. * cancer. * psychiatric disorders. * severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder. * hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion. * participating in another clinical trial that could affect glucose measurements or glucose management. * in the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.

Keywords: ambulatory glucose profile time in range fear of hypoglycemia continuous glucose monitoring
french national observatory on infective endocarditis

Conditions: Infective Endocarditis

Summary: the objective of this observatory is to provide a national database of infective endocarditis, informed by all volunteer centers, using a standardized case report forms. such an observatory will describe the clinical profile, microbiological, therapeutic and evolving of infective endocarditis (ie); analyze the risk factors for the disease and its prognosis factors of evolution; describe management practices; evaluate and compare in the real drug treatment strategies (including antibiotics) and surgical.

all the clinical, biological, microbiological and laboratory describing the history of patients and their evolution during hospitalization for infective endocarditis will be obtained from physicians supporting patients and recorded in an electronic case report form. will include collected clinical characteristics (site, pre-existing heart disease underlying symptoms, complications), biological characteristics (dosage on admission and diagnosis), microbiological characteristics (identifying the genus and species of the microorganism responsible, sensitivity to antibiotics susceptibility testing and evaluated by determination of minimal inhibiting concentration (mic), exhaustive search of the rare forms of endocarditis uncultivated microorganisms), an analysis of the gateways based on the causative organism; echocardiographic characteristics (number and size of vegetations, valvular damage, scalable: surgery, lethality) and therapeutic characteristics (antibiotic treatment, surgical).

Eligibility criteria:
inclusion criteria: * major patient * supported in one of the participating centers * the application of diagnostic classification criteria of duke modified by li is carried out after collection of all the data at the end of the patient's hospitalization. only patients meeting criteria for definite or possible endocarditis will be included in the analyses. * registered with the french social security system exclusion criteria: • refusal of the patient to participate.
effectiveness of nurse-delivered care for adherence/mood in hiv in south africa

Conditions: Immunodeficiency Virus, Human; Depressive Symptoms

Summary: the purpose of this study is to conduct a two-arm effectiveness trial in cape town, south africa of a xhosa-adapted, nurse-delivered, cognitive behavioral therapy (cbt) treatment for depression and adherence, integrated into the hiv care setting in patients with hiv who did not achieve viral suppression from first-line treatment. the cbt treatment will be compared to enhanced usual care (enhanced treatment as usual - etau) on study endpoints (as described in study endpoints section below).

clinical clinical depression is one of the highest comorbidities to hiv/aids, with estimated rates up to 34.9 percent. depression, in the context of hiv, leads to poor self-care behavior such as non-adherence to art and worse retention in care, which are critical for treatment success. based on our prior work, and given that cbt is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the hiv primary care setting in s. africa. to ensure that those who need this intervention the most will receive it, participants will be patients with hiv who did not achieve viral suppression from their first line art, and have a unipolar depressive mood disorder.

Eligibility criteria:
inclusion criteria: * hiv-seropositive * current diagnosis of depression * did not attain viral suppression from first-line arv per local clinic standard exclusion criteria: * unable or unwilling to provide informed consent. * active untreated, major mental illness (untreated psychosis or mania) that would interfere with cbt-ad. * has not received cbt for depression. * less than 18 years of age.
lack of decision-making in patients with alzheimer's disease : functions involved and the daily consequences

Conditions: Alzheimer Disease

Summary: early in its development, alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of alzheimer's disease. however, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. in addition, decision-making is generally assessed using a test called the iowa gambling task (igt), which, despite its many advantages, does not have established ecological validity. in the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life. in this study, the investigators seek to better define the disorder by decision-making in early alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.


Eligibility criteria:
inclusion criteria for patients with alzheimer's disease : * mini-mental state examination \> 23 * stable treatment for at least two months * mother tongue : french inclusion criteria for control : * general cognitive level in the standard on the following tests : mini-mental state examination and fast front end efficiency battery * mother tongue : french exclusion criteria for patients with alzheimer's disease : * game addiction * uncorrected visual and hearing disorders * other neurological or psychiatric history * inability to communicate * delusional or psychotic state exclusion criteria for control : * game addiction * psychiatric or neurological disorders * anxiety and depression symptomatology

Keywords: decision making iowa gambling task
cannabinoid medication for adults with ocd

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this pilot research study is to test the effects of a medication called nabilone (cesamet) in adults with obsessive-compulsive disorder (ocd). participants will receive either nabilone on its own, or nabilone in combination with a form of cognitive-behavioral therapy (cbt) called exposure and response prevention (ex/rp). nabilone is a synthetic cannabinoid and acts on the brain's "endocannabinoid system," which has been hypothesized to play a role in ocd. nabilone is approved by the fda for the treatment of chemotherapy-induced nausea and vomiting. it is not fda-approved for treating ocd.

the two first-line treatments for ocd are a class of medications called serotonin reuptake inhibitors (sris) and a type of cognitive behavioral therapy called exposure and response prevention (ex/rp). but more than a third of patients with ocd do not respond to these treatments, and less then half become well. thus, new treatment approaches are needed. ex/rp is thought to involve fear extinction learning. recent research suggests that modulators of the endocannabinoid system such as nabilone (a synthetic cannabinoid and agonist of the cannabinoid 1 receptor, cb1r) may enhance fear extinction learning and therefor could enhance ex/rp. however, nabilone could also work via modulating activity in cortico-striatal circuits, which contain high concentrations of cb1r, and thereby might reduce repetitive behaviors like compulsions seen in ocd. to test both ideas, we will conduct a small pilot randomized trial to explore the effects of nabilone on its own for 4 weeks, vs. combined with ex/rp, in adult patients with ocd. this proof-of-concept study will investigate whether nabilone administration is feasible and well-tolerated in adult patients with ocd. the intent is to collect pilot data to support future grant applications.

Eligibility criteria:
inclusion criteria: * age 18-60 * physically healthy, not pregnant * primary obsessive-compulsive disorder (ocd) * patient off all psychotropic (except selective serotonin reuptake inhibitors \[ssris\]) and other types of drugs likely to interact with nabilone * ability to provide informed consent * ability to tolerate a treatment free-period exclusion criteria: * history of any significant medical condition that may increase the risk of participation * females who are pregnant or nursing * current or lifetime history of psychiatric disorders other than ocd that may increase the risk of participation (e.g. lifetime psychosis or bipolar disorder) * current substance use disorder or positive urine toxicology at screening, or any adverse reaction to a cannabinoid * patients already receiving ex/rp
changing lower back pain through virtual reality

Conditions: Low Back Pain

Summary: the main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (vr) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (rom), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without vr (control group).

chronic pain is considered an urgent global public health problem. one of the most prevalent chronic pain pathologies worldwide is low back pain (lbp). kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in lbp; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of lbp.(20-22) however, the efficacy of physical reconditioning programs developed so far would require considerable improvement. the induction of illusions in virtual reality (vr) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. the main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with vr manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (rom), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without vr (control group).

Eligibility criteria:
inclusion criteria: * diagnosis of chronic non-specific lower back pain according to the european cost b13 guideline. * pain score of 3 or higher on the numeric rating scale (nrs) in the last 6 months. exclusion criteria: * presence of spinal tumor. * presence of infection. * presence of fracture. * presence of systemic disease. * presence of fibromyalgia. * presence of cauda equina syndrome. * previous spinal surgery. * presence of musculoskeletal injuries of the lower extremities.

Keywords: virtual reality physical activity range of movement pain disability kinesophobia